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Active, Not Recruiting

NCT Number: NCT06594315

Assessing Brain Metabolism Using MRS With Deuterated Glucose

This study will investigate the use of Hydrogen 1 (1H) magnetic resonance spectroscopy (MRS) with deuterated glucose (2H-glucose) to detect dynamic glucose uptake in the brain.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University of California, San Francisco

San Francisco, California, 94143, United States

About this study

PRIMARY OBJECTIVE:

  • To define the most appropriate imaging parameters of 1H MRS for obtaining deuterium-labeled glucose metabolism (Cohorts 1 and 2).
  • To evaluate treatment induced metabolic changes after the administration of 2H-glucose in participants with glioma (Cohort 3).

OUTLINE:

Participants with and without glioma will be evaluated to develop a robust strategy for obtaining 2H-glucose metabolism in twenty healthy participants (cohort 1) and thirty participants with glioma (cohort 2), while the remaining thirty glioma participants will be studied at baseline and after completion of non-investigational therapy (cohort 3).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Participants must be >= 18 years old
  • Cohort 1: Healthy controls
  • Cohort 2: Participants with histological proven glioma who have evidence of evaluable disease (with contrast enhancing lesion or non-enhancing lesion > 4 cc) based on a prior MR scan, Karnofsky performance status of >=70 and life expectancy > 4 weeks.
  • Cohort 3: Participants with histologically proven glioma who will be undergoing any treatment, Karnofsky performance status of >=70 and life expectancy > 12 weeks.
  • Participants must not have any significant medical illness that in the investigator's opinion cannot be adequately controlled with appropriate therapy, would compromise the subject's ability to participate in this study or any disease that will obscure toxicity or dangerously impact response to the imaging agent.
  • Participants must not have a history of any other cancer unless they are in complete remission and have been off all therapy for that disease for a minimum of 3 years.
  • Participants must not be pregnant or breast-feeding. Persons of childbearing potential are required to obtain a negative serum or urine pregnancy test within 14 days of the scan. Effective contraception (men and women) must be used in subjects of childbearing potentials.
  • Participants must sign an informed consent indicating that they are aware of the investigational nature of the study

Exclusion criteria

Participants must be excluded from participating in this study if they are not able to comply with the study and/or follow-up procedures.

  • Participants exceeding the weight limitations of the scanner (300 pounds)
  • Inability to lie still for the entire imaging time (e.g., cough, severe arthritis, etc.)
  • Inability to complete the study due to other reasons (severe claustrophobia, MR incompatible medical implants or devices, inability to comply with pre-procedure fasting, etc.)
  • Pre-examination blood glucose level of > 120 mg/dL as measured by point of care finger stick blood glucose test prior to MR examination.
  • Participants, either healthy volunteers (recruited for cohort 1) or participants with glioma (for cohorts 2 &3), have history of diabetes mellitus.

Treatment and study plan

Deuterated Glucose

Drug

Given orally

Other names: Hydrogen gas (H2) glucose, [6,6'-2H2] glucose

Magnetic Resonance Imaging (MRI)

Procedure

Imaging procedure performed at University of California, San Francisco

Other names: MRI

Blood sample

Procedure

Capillary blood from the fingertip

MR spectroscopy (MRS)

Procedure

Imaging procedure performed at University of California, San Francisco

Other names: MRS

Primary outcomes

  1. Signal-to-noise ratio (Cohort 1 & 2)

    Time frame: Day of imaging (1 day)

    The signal-to-noise ratio (SNR) in metabolite concentrations will be calculated and compared on a voxel-by-voxel basis and via summary parameters (mean, median, and max) from the regions of interest (ROIs) of the anatomic and metabolic lesions on the imaging scan. Peaks with SNR > 5.0 are considered detectable

  2. Mean difference in metabolite concentrations (Cohort 1 & 2)

    Time frame: Day of imaging (1 day)

    Mean difference in metabolite concentrations of 2H labeling of these metabolites will be calculated and compared on a voxel-by-voxel basis and via summary parameters (mean, median, and max) from the ROIs of the anatomic and metabolic lesions.

  3. Mean difference in fractional enrichment (Cohort 1 & 2)

    Time frame: Day of imaging (1 day)

    Mean difference in fractional enrichment of 2H labeling of these metabolites will be calculated and compared on a voxel-by-voxel basis and via summary parameters (mean, median, and max) from the ROIs of the anatomic and metabolic lesions.

  4. Mean metabolic turnover over time (Cohort 3)

    Time frame: Up to 21 days after the completion of non-investigational treatment

    Estimates of the extent of change over time following non-investigational treatment obtained at the baseline and one repeated after receiving treatment will be compared.

Sponsors and collaborators

Lead sponsor

University of California, San Francisco

Other

Registry information

Official study title

Assessing Brain Metabolism Using 1H MRS With Deuterated Glucose

Important dates

Study start
2022
Primary completion
2027
Study completion
2027
First posted
Sep 19, 2024
Registry last updated
Sep 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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